Medtech startups, just like established companies, also have great, visionary ideas. Unfortunately, many startups often get lost in the dense medtech jungle on the path to market approval. Also valid for the medtech industry: the only constant is change. Our experts at konplan know this all too well.

The major challenge is to pave the way for bringing medtech innovations safely and efficiently through this obstacle course. So, the question is: How can companies keep pace with constant change and increasing regulatory requirements while avoiding obstacles and potential pitfalls?

Typical obstacles and pitfalls where medtech companies fail

Regulatory Mindset – the regulatory mindset of the company is inadequate or insufficient. Medtech manufacturers, especially those new to the market, often lack guidelines for the development and production of medtech products and do not understand the benefits of medical device regulation.

Many prototypes and near-series products are created without paying proper attention to the requirements for medical device approval. Inevitably, this will have an undesirable effect when the device is submitted for market approval.

Moving Target – at the beginning of a development project, the development plan and the specific requirements are often not clarified. Clarification only happens during the project based on customer feedback and experiences. Major time pressures in development projects make this the reality of today.

Speed, flexibility, and agility are critical success factors in the market. For companies, this means shorter development iterations. Systems engineering, requirements engineering, and agile frameworks are suitable handling methods. Regulatory authorities require a value proposition (i.e., proven benefit – medical and economic).

The concept of minimum viable product (MVP) is a good solution. When used effectively, this approach can be a convincing strategy to assess product suitability for the market in a timely manner – acceptance is often the greatest risk for a new medical product company.

Time to market – or a path to success without detours. You will not get a second chance to get it right the first time! Getting it “right” the first time may take a little longer than originally desired, but it is always faster than doing it a second time. The continuous innovation and development of medical devices and their related technologies requires a considerable amount of time, money, and resources.

These projects also require the simultaneous cooperation of various internal and external teams with competencies in project management and risk management as well as the necessary medical expertise and usability experience in a regulated environment. It is very important to correctly distribute and prioritize the time and resources used for critical tasks.

Tools and techniques should be used which allow developing medical products faster and more efficiently. However, the products must be safe and effective – quality and safety come first – get it right the first time!

At konplan, we believe it is important to give innovations a real chance and not let them just fall by the wayside. We know the obstacles and potential pitfalls in the medtech jungle.

When is konplan the right partner?

konplan systemhaus ag paves your way through the medtech jungle, regardless of whether you want to revolutionize the market or simply improve established processes and products. We are not only competent within the framework of development projects for large international companies, but also in research collaborations with universities and funding institutions (CH, EU).

We offer extensive expertise and experience:

• Project Management
• Risk Management
• Embedded Systems Engineering
• Mechanical Engineering and Automation
• Software and Quality Engineering
• Proof of Concepts
• Implementation of medtech innovations across all development steps
• Dealing with the pain points of startups
• QMS structure, Development file (DHF, STED)

If required, we offer you access to our excellent partner network.

It is our mission and our passion, as a competent guide, to support new ideas and projects in the medtech industry. With our expertise, we help master the challenges of the medtech industry in a professional manner. This gives our customers the ability to focus on their innovative and value adding activities.

Developing together! We put your ideas into practice and accompany your projects until they are ready for the market. Get in touch with our experts now.